The TLDR: The Brazilian government’s deal to import 20 million doses of Bharat Biotech’s Covaxin has sparked an investigation into corruption—raising questions about the involvement of President Bolsonaro and about the vaccine itself.

Tell me about this deal...

In January—soon after Covaxin was approved for emergency use in India—members of the Brazilian Congress proposed buying the vaccine under the “exceptional importation” scheme—which would allow for a fast-track approval. Soon after, President Jair Bolsonaro called PM Modi expressing interest in Covaxin. And in a deal signed in February, the Brazilian Health ministry agreed to pay $320 million for 20 million doses of Covaxin—at an eye-watering price of $15 per dose. The agreement was signed with a ‘middleman’ company called Precisa Medicamentos.

Ok, so what’s wrong with it?

Bolsonaro’s mishandling of the pandemic is currently being investigated by a parliamentary commission—which is holding televised hearings that are on the front page of every newspaper. And two big government contracts—one to buy Covaxin and the other to purchase raw materials for the drug Hydroxychloroquine—have raised a lot of red flags for the following reasons:

One: Bolsonaro was first a notorious Covid-denier and later fiercely resistant to vaccines. In December, he strongly warned against Pfizer vaccines:

“In the Pfizer contract it's very clear: 'we're not responsible for any side effects.' If you turn into a crocodile, it's your problem… If you become superhuman, if a woman starts to grow a beard or if a man starts to speak with an effeminate voice, they will not have anything to do with it.”

He also made clear that no vaccine will be distributed in Brazil without the approval of Brazil’s top health regulatory agency, ANVISA (Agência Nacional de Vigilância Sanitária). And yet, come January, he suddenly changed his tune, as the vice president of the parliamentary commission notes:

“Suddenly we discover that on January 8, Bolsonaro made another call to the prime minister of India asking for the vaccine from Bharat Biotech, Covaxin, which had not yet been registered with ANVISA. Then we found out that a company here in Brazil was marketing this vaccine and the representative of that company was in New Delhi on January 6. On January 8, Bolsonaro calls the prime minister of India showing an interest in buying this vaccine.”

Two: Covaxin is also the only vaccine in Brazil that was bought via a middleman—and not directly from the manufacturer. Internal documents suggest that Precisa Medicamentos was paid $100 million—a third of the total amount—for its services. But the Health Ministry denies making any such payment. 

Three: The Brazilian government announced the deal at a time when phase 3 data for Covaxin’s trials in India were not available—and had not held phase 3 trials in Brazil. And it had not been approved by ANVISA—which Bolsonaro insisted was a must. All the three vaccines currently being distributed in Brazil—Sinovac, AstraZeneca and Pfizer—were authorised by ANVISA after holding phase-3 trials in Brazil.

Four: At $15 a dose, Covaxin is also way more costly than any of the other vaccines—though Precisa claims it is the same as the price negotiated with 13 other countries. It is the single most expensive vaccine deal made by Brazil. 

Five: A health ministry official told prosecutors that he was pressured to push through the import agreement for Covaxin by aides of one of Bolsonaro’s closest allies—the former Health Minister. A congressman said: "It's a visible attempt to extract public money without a documented purpose, with an inflated value and ulterior motives."

The HCQ angle: There is a clear pattern in Bolsonaro’s willingness to lobby for certain kinds of medicines—especially in his relationship with Modi. Media reports have also focused on a personal call made by the president in April, 2020, to request the release of raw materials for the drug hydroxychloroquine—an immunosuppressive that has proven to be ineffective in treating Covid. But he made the appeal on behalf of two big drug manufacturers in Brazil, EMS and Apsen—name-checking them in his conversation with the PM. And when his request was quickly granted, Bolsonaro shared a fawning thank you message on Twitter comparing it to “the holy medicine” brought by Lord Hanuman… to save the life of Lord Rama’s brother Laksmana.”

Point to note: Owners of EMS and Apsen are big supporters of Bolsonaro. And the parliamentary commission is looking at whether far-right groups close to Bolsonaro got a cut in the exorbitant deal with Bharat Biotech. As the commission’s president says, “We want to know who made money from it and what was the purpose of these people.”

So this is about corruption, not Covaxin itself, right?

Actually, the controversy in Brazil doesn’t help Covaxin’s cause either. To date, the country has not administered a single dose of the vaccine. That’s because in April, ANVISA rejected Covaxin’s application (after the deal had been signed) after inspecting its manufacturing facility in Hyderabad. The agency listed a number of serious problems:

• Covaxin uses an inactivated (dead) coronavirus which when delivered into the body triggers an immune response. ANVISA said Bharat Biotech has “not validated the method used to inactivate, or kill, the virus, which may cause contamination of patients with the Sars-CoV2 virus itself.”
• The company also did not use control methods to ensure that every dose has the same potency.
• And ANVISA said that there were insufficient controls to ensure the sterility and purity of the vaccine.

ANVISA’s conclusion was that Bharat Biotech had not followed the standards set by global Good Manufacturing Practices—and concluded that these violations denoted “a significant risk to the manufacture and quality assurance of the product, implying a health risk to users.”

The bottomline: In June, ANVISA finally approved four million doses of Covaxin, but imposed very strict conditions. The Wire best sums up the future of Covaxin in Brazil:

“But the vaccine can’t be imported and given until the phase-3 trials are completed in Brazil and its reports analysed by ANVISA after two months of the second dose to volunteers. As the trial has not started yet, it will be months before the first dose of Covaxin is introduced in Brazil. By that time the parliamentary commission would have wrapped up (mid-August) and probably sealed the fate of Covaxin.”

Reading list

The Wire has the best coverage of the corruption case and the HCQ angle—sourced from correspondents in Brazil. We highly recommend reading Priyanka Pulla’s detailed reporting in Quint on why ANVISA rejected Covaxin. She also wrote this deep dive in Mint on how vaccine triumphalism has undermined Covaxin from the very beginning.